Blog
RSS FeedPosted by Michael Wonder on 03 Apr 2018
Eisai submits supplemental new drug application to FDA for Fycompa (perampanel) paediatric indications
31 March 2018 - First step to making Fycompa available for children, underscoring Eisai's commitment to epilepsy care for patients of ...
Posted by Michael Wonder on 03 Apr 2018
Alkermes receives refusal to file letter from FDA for ALKS 5461
2 April 2018 - Alkermes today announced that it received a refusal to file letter from the U.S. FDA regarding ...
Posted by Michael Wonder on 30 Mar 2018
Sunovion submits new drug application to the FDA for apomorphine sublingual film (APL-130277) for the treatment of off episodes associated with Parkinson's disease
30 March 2018 - Submission is supported by Phase 3 clinical study data showing that the investigational medicine demonstrated superior efficacy ...
Posted by Michael Wonder on 30 Mar 2018
Statement from FDA Commissioner on FDA’s efforts to enhance the patient perspective and experience in drug development and review
30 March 2018 - Benefit-risk assessment is at the heart of what we do to ensure that Americans have access ...
Posted by Michael Wonder on 30 Mar 2018
Insmed submits new drug application to FDA for ALIS in NTM lung disease caused by MAC
29 March 2018 - ALIS previously designated as an orphan drug, breakthrough therapy and qualified infectious disease product. ...
Posted by Michael Wonder on 29 Mar 2018
FDA expands approval of Blincyto for treatment of a type of leukaemia in patients who have a certain risk factor for relapse
29 March 2018 - The U.S. FDA granted accelerated approval to Blincyto (blinatumomab) to treat adults and children with B-cell precursor ...
Posted by Michael Wonder on 29 Mar 2018
Mylan introduces Symfi triple combo once-daily HIV treatment in the U.S.
28 March 2018 - All ARV regimens are being offered at a significant discount to the price of competing products to ...
Posted by Michael Wonder on 28 Mar 2018
To make copycat drugs more competitive, the FDA is taking a harder look at the originals
28 March 2018 - The FDA wants to improve branded drugs to help bolster the biosimilars market. ...
Posted by Michael Wonder on 28 Mar 2018
FDA approves Toujeo Max SoloStar
27 March 2018 - Max SoloStar holds more insulin than any other long-acting insulin pen. ...
Posted by Michael Wonder on 27 Mar 2018
FDA authorises first fully interoperable continuous glucose monitoring system, streamlines review pathway for similar devices
27 March 2018 - The U.S. FDA today permitted marketing of the Dexcom G6 integrated continuous glucose monitoring (iCGM) system for ...
Posted by Michael Wonder on 27 Mar 2018
U.S. FDA accepts Bristol-Myers Squibb’s application for Opdivo (nivolumab) plus Yervoy (ipilimumab) for previously treated patients with MSI-H or dMMR metastatic colorectal cancer for priority review
27 March 2018 - The FDA also granted the Opdivo plus Yervoy combination breakthrough therapy designation for this potential indication. ...
Posted by Michael Wonder on 27 Mar 2018
Lexicon Pharmaceuticals announces regulatory submissions for sotagliflozin to treat adults with type 1 diabetes
26 March 2018 - New drug application submitted to U.S. FDA and marketing authorisation application submitted to EMA. ...
Posted by Michael Wonder on 27 Mar 2018
Palatin Technologies announces submission of bremelanotide NDA to FDA for treatment of hypoactive sexual desire disorder in premenopausal women
26 March 2018 - Palatin Technologies announced today that its exclusive North American licensee for bremelanotide, AMAG Pharmaceuticals, has submitted a ...
Posted by Michael Wonder on 27 Mar 2018
Bayer announces completion of rolling submission of new drug application in the U.S. for larotrectinib for the treatment of TRK fusion cancer
26 March 2018 - Bayer today announced that its collaboration partner Loxo Oncology has completed the rolling submission of a new ...
Posted by Michael Wonder on 26 Mar 2018
Seattle Genetics and Astellas receive FDA breakthrough therapy designation for enfortumab vedotin in locally advanced or metastatic urothelial cancer
26 March 2018 - Seattle Genetics and Astellas Pharma today announced that the U.S. FDA has granted breakthrough therapy designation ...